E-bibliotherapy for Informal Caregivers of People With Dementia

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05927805
Collaborator
Health and Medical Research Fund (Other)
192
2
36

Study Details

Study Description

Brief Summary

The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.

Condition or Disease Intervention/Treatment Phase
  • Other: E-bibliotherapy
  • Other: Control
N/A

Detailed Description

This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Eight weekly sessions of e-bibliotherapy. Participants in the intervention group will use the e-bibliotherapy app we develop, and accept e-bibliotherapy via the app.

Other: E-bibliotherapy
Participants in the intervention group will accept eight weekly sessions of e-bibliotherapy. The e-bibliotherapy will be delivered via the e-bibliotherapy app we develop and includes eight e-bibliotherapy sessions, each focusing on one active component that may affect a caregiver's mental well-being.

Sham Comparator: Control group

Eight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app.

Other: Control
The control group will give access to the same e-bibliotherapy app, but only be authorized to access general daily living knowledge that is different from the intervention contents. They will also be asked to finish a session each week for eight weeks.

Outcome Measures

Primary Outcome Measures

  1. Changes on psychological well-being [Pre-intervention, immediately post-intervention, three and six-month post-intervention]

    Psychological well-being will be measured by the Chinese version of Ryff's Psychological Well-being Scale. It is a 6-point Likert scale with 1=strongly disagree to 6=totally agree. It includes 18 items. A higher score indicates better psychological well-being.

Secondary Outcome Measures

  1. Changes on caregiving appraisal [Pre-intervention, immediately post-intervention, three and six-month post-intervention]

    Caregiving appraisal will be measured by the Chinese version of the Caregiving Appraisal Scale. It is a 5-point Likert scale (1=extremly disagree, 5=strongly agree) including 26 items. Higher scores indicate more positive caregiving appraisal.

  2. Changes on mental health [Pre-intervention, immediately post-intervention, three and six-month post-intervention]

    Mental health will be measured by the Chinese version of the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 is a 4-point Likert scale (0=totally unfit my condition, 3=very fit my condition). It includes 21 items. Higher scores indicate worse mental health problems.

  3. Changes on biomarker of stress [Pre-intervention, immediately post-intervention, three and six-month post-intervention]

    Saliva cortisol concentration will be used.

  4. Changes on health-related quality of life [Pre-intervention, immediately post-intervention, three and six-month post-intervention]

    Health-related quality of life will be measured by the 12-item Short Form Survey (SF-12). SF-12 includes 12 items. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • primary caregivers aged 18 or above;

  • provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4~6);

  • have cared for the care recipient for at least six months;

  • assist with at least one of the care recipient's daily activities;

  • use a smartphone or tablet;

  • can read Chinese.

Exclusion Criteria:
  • caregivers with unstable physical or mental conditions;

  • have cognitive impairment;

  • are undergoing acute treatment or have not yet stabilized on their chronic medication;

  • are involved in another interventional study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Hong Kong Polytechnic University
  • Health and Medical Research Fund

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05927805
Other Study ID Numbers:
  • HSEARS20221020009
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023